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M-Brace Air

INDACO SRL · Model 40 XXL · UDI-DI 05391512280321

ITQ
10
510(k) clearances
493
Adverse events
12
Recalls
454
Facilities

Description

Vega Patella Stabilizer Knee brace is for both right and left knees providing optimal support and protection following muscle, joint or tendon injuries in the region of the patella. Constructed exclusively from breathable hypoallergenic fabrics (Neoprene-free and Latex-free), the area which comes into contact with the skin is made of soft 100% cotton. An exclusive handy locking system allows the required pressure to be varied in three different areas. Featuring two unique C-shaped pressure pads which, when brought together as the brace is secured, surround and stabilize the patella. 2 low profile 2 mm super light rods, to keep the brace in place 2 replacement super light rods (for product 40 only) 2 multi-centric molded aluminum hinges (LATERAL and MEDIAL, product 41 only) for improved lateral support in cases of patella related pathologies associated with minor instability of medial and/or lateral collateral ligaments.

Recalls

DateFirmReason
2020-06-18Mueller Sports Medicine, IncNatural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex".
2019-11-21DeRoyal Industries IncThe Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.
2016-02-24Ossur H / FOssur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12CorflexKnee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.